QOL After SURGERY and ADJUVANT Treatment

NCT ID: NCT06115239

Last Updated: 2024-05-07

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-05-31
• Study Completion Date: 2026-01-31

Brief Summary

The goal of this prospective, observational study is to measure and analyze the effect of adjuvant treatment over the quality of life and recovery of patients undergoing pulmonary resection because of non-small cells lung cancer using the EORTC-LC29 questionnaire. The main question it aims to answer is:

Whether adjuvant systemic treatment affect or not the postoperative QOL of a NSCLC patient that underwent lung resection

Participants will fulfill two questionnaires (EORTC-LC29 and Hospital Anxiety and Depression Scale) in different stages of their treatment.

Detailed Description

Despite being surgery the preferred radical treatment of NSCLC in early stages, unforseen N2 disease, larger tumors or bad prognosis histological or molecular findings of the tumor will benefit of receiving adjuvant treatment.

As an adjuvant treatment, postoperative platinum-based chemotherapy has demonstrated its efficacy in increasing survival rates and reducing recurrence rates. Postoperative radiotherapy (RT) is limited due to decreased lung tolerance following surgery and conflicting results.

It is clear that lung cancer significantly impacts the quality of life of patients. According to the Lung Cancer Europe (LuCE) association, a survey conducted in 2021 with 515 patients revealed that 91.2% experienced limitations in their daily lives. Fatigue, sleep problems, cognitive difficulties, and significant reductions in physical activity were the main areas where patients reported the most complications. In addition to the inherent complications of cancer, we must consider the complications associated with surgery and systemic treatment.

Module LC29 is an update of the previous module published by the European Organisation for Research and Treatment of Cancer (EORTC), providing a more current perspective on lung cancer. This latest module retains 12 out of the 13 items from LC13 and adds 17 new items, which gather information on the side effects of medical and targeted therapies, as well as emotional problems. Furthermore, it includes 5 specific questions related to lung surgery. This multidisciplinary approach currently makes the LC29 questionnaire the most comprehensive tool for studying the quality of life of lung cancer patients.

Conditions

Carcinoma, Non-Small-Cell Lung; Quality of Life

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

Questionnaires

The patients will fulfill the EORTC-LC29 and HADS questionnaires in 5 different moments.

Intervention Type: OTHER

Other Intervention Names

Surveys

Eligibility Criteria

Inclusion Criteria

• Age: 50-85 years old
• Patients with any histological type of non-small-cell lung cancer in clinical stage T1C N0M0 or greater
• Patients that understand the purpose of the study, accept collaborate and sign the informed consent.

Exclusion Criteria

• Patients not receiving adjuvant treatment due to complications, bad quality of life or express rejection at any moment of the curse of the process.
• Patients who cannot complete the previous questionnaires to assess their quality of life

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Salamanca

OTHER

Sponsor Role: lead

Responsible Party

Pablo Fernandez Salvador

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pablo Fernández Salvador, Nurse

Role: PRINCIPAL_INVESTIGATOR

University of Salamanca

Nuria M Novoa Valentín, MD, PhD

Role: STUDY_DIRECTOR

University of Salamanca

Marta G Fuentes Gago, MD, PhD

Role: STUDY_DIRECTOR

University of Salamanca

María B García Cenador, MD, PhD

Role: STUDY_CHAIR

University of Salamanca

Locations

Hospital Clínico Universitario

Salamanca, , Spain

Countries

Spain

Central Contacts

Pablo Fernández Salvador, Nurse

Role: CONTACT

pfs45@usal.es

+34 689147857

References

Siegel RL, Miller KD, Wagle NS, Jemal A. Cancer statistics, 2023. CA Cancer J Clin. 2023 Jan;73(1):17-48. doi: 10.3322/caac.21763.

Reference Type: BACKGROUND

PMID: 36633525 (View on PubMed)

Nicholson AG, Tsao MS, Beasley MB, Borczuk AC, Brambilla E, Cooper WA, Dacic S, Jain D, Kerr KM, Lantuejoul S, Noguchi M, Papotti M, Rekhtman N, Scagliotti G, van Schil P, Sholl L, Yatabe Y, Yoshida A, Travis WD. The 2021 WHO Classification of Lung Tumors: Impact of Advances Since 2015. J Thorac Oncol. 2022 Mar;17(3):362-387. doi: 10.1016/j.jtho.2021.11.003. Epub 2021 Nov 20.

Reference Type: BACKGROUND

PMID: 34808341 (View on PubMed)

Ettinger DS, Wood DE, Aisner DL, Akerley W, Bauman JR, Bharat A, Bruno DS, Chang JY, Chirieac LR, D'Amico TA, DeCamp M, Dilling TJ, Dowell J, Gettinger S, Grotz TE, Gubens MA, Hegde A, Lackner RP, Lanuti M, Lin J, Loo BW, Lovly CM, Maldonado F, Massarelli E, Morgensztern D, Ng T, Otterson GA, Pacheco JM, Patel SP, Riely GJ, Riess J, Schild SE, Shapiro TA, Singh AP, Stevenson J, Tam A, Tanvetyanon T, Yanagawa J, Yang SC, Yau E, Gregory K, Hughes M. Non-Small Cell Lung Cancer, Version 3.2022, NCCN Clinical Practice Guidelines in Oncology. J Natl Compr Canc Netw. 2022 May;20(5):497-530. doi: 10.6004/jnccn.2022.0025.

Reference Type: BACKGROUND

PMID: 35545176 (View on PubMed)

Shi Y, Wu S, Ma S, Lyu Y, Xu H, Deng L, Chen X. Comparison Between Wedge Resection and Lobectomy/Segmentectomy for Early-Stage Non-small Cell Lung Cancer: A Bayesian Meta-analysis and Systematic Review. Ann Surg Oncol. 2022 Mar;29(3):1868-1879. doi: 10.1245/s10434-021-10857-7. Epub 2021 Oct 6.

Reference Type: BACKGROUND

PMID: 34613537 (View on PubMed)

Atkins BZ, Harpole DH Jr, Mangum JH, Toloza EM, D'Amico TA, Burfeind WR Jr. Pulmonary segmentectomy by thoracotomy or thoracoscopy: reduced hospital length of stay with a minimally-invasive approach. Ann Thorac Surg. 2007 Oct;84(4):1107-12; discussion 1112-3. doi: 10.1016/j.athoracsur.2007.05.013.

Reference Type: BACKGROUND

PMID: 17888955 (View on PubMed)

Scott WJ, Allen MS, Darling G, Meyers B, Decker PA, Putnam JB, McKenna RW, Landrenau RJ, Jones DR, Inculet RI, Malthaner RA. Video-assisted thoracic surgery versus open lobectomy for lung cancer: a secondary analysis of data from the American College of Surgeons Oncology Group Z0030 randomized clinical trial. J Thorac Cardiovasc Surg. 2010 Apr;139(4):976-81; discussion 981-3. doi: 10.1016/j.jtcvs.2009.11.059. Epub 2010 Feb 20.

Reference Type: BACKGROUND

PMID: 20172539 (View on PubMed)

Whitson BA, Groth SS, Duval SJ, Swanson SJ, Maddaus MA. Surgery for early-stage non-small cell lung cancer: a systematic review of the video-assisted thoracoscopic surgery versus thoracotomy approaches to lobectomy. Ann Thorac Surg. 2008 Dec;86(6):2008-16; discussion 2016-8. doi: 10.1016/j.athoracsur.2008.07.009.

Reference Type: BACKGROUND

PMID: 19022040 (View on PubMed)

Pignon JP, Tribodet H, Scagliotti GV, Douillard JY, Shepherd FA, Stephens RJ, Dunant A, Torri V, Rosell R, Seymour L, Spiro SG, Rolland E, Fossati R, Aubert D, Ding K, Waller D, Le Chevalier T; LACE Collaborative Group. Lung adjuvant cisplatin evaluation: a pooled analysis by the LACE Collaborative Group. J Clin Oncol. 2008 Jul 20;26(21):3552-9. doi: 10.1200/JCO.2007.13.9030. Epub 2008 May 27.

Reference Type: BACKGROUND

PMID: 18506026 (View on PubMed)

Butts CA, Ding K, Seymour L, Twumasi-Ankrah P, Graham B, Gandara D, Johnson DH, Kesler KA, Green M, Vincent M, Cormier Y, Goss G, Findlay B, Johnston M, Tsao MS, Shepherd FA. Randomized phase III trial of vinorelbine plus cisplatin compared with observation in completely resected stage IB and II non-small-cell lung cancer: updated survival analysis of JBR-10. J Clin Oncol. 2010 Jan 1;28(1):29-34. doi: 10.1200/JCO.2009.24.0333. Epub 2009 Nov 23.

Reference Type: BACKGROUND

PMID: 19933915 (View on PubMed)

Wang SF, Mao NQ, Zhao WH, Pan XB. Postoperative radiotherapy in pIIIA-N2 non-small cell lung cancer after complete resection and adjuvant chemotherapy: A meta-analysis. Medicine (Baltimore). 2022 Jul 15;101(28):e29550. doi: 10.1097/MD.0000000000029550.

Reference Type: BACKGROUND

PMID: 35839025 (View on PubMed)

Forde PM, Chaft JE, Smith KN, Anagnostou V, Cottrell TR, Hellmann MD, Zahurak M, Yang SC, Jones DR, Broderick S, Battafarano RJ, Velez MJ, Rekhtman N, Olah Z, Naidoo J, Marrone KA, Verde F, Guo H, Zhang J, Caushi JX, Chan HY, Sidhom JW, Scharpf RB, White J, Gabrielson E, Wang H, Rosner GL, Rusch V, Wolchok JD, Merghoub T, Taube JM, Velculescu VE, Topalian SL, Brahmer JR, Pardoll DM. Neoadjuvant PD-1 Blockade in Resectable Lung Cancer. N Engl J Med. 2018 May 24;378(21):1976-1986. doi: 10.1056/NEJMoa1716078. Epub 2018 Apr 16.

Reference Type: BACKGROUND

PMID: 29658848 (View on PubMed)

Shukla N, Hanna N. Neoadjuvant and Adjuvant Immunotherapy in Early-Stage Non-Small Cell Lung Cancer. Lung Cancer (Auckl). 2021 Jun 28;12:51-60. doi: 10.2147/LCTT.S277717. eCollection 2021.

Reference Type: BACKGROUND

PMID: 34234606 (View on PubMed)

Broderick SR. Adjuvant and Neoadjuvant Immunotherapy in Non-small Cell Lung Cancer. Thorac Surg Clin. 2020 May;30(2):215-220. doi: 10.1016/j.thorsurg.2020.01.001.

Reference Type: BACKGROUND

PMID: 32327180 (View on PubMed)

Paz-Ares L, Luft A, Vicente D, Tafreshi A, Gumus M, Mazieres J, Hermes B, Cay Senler F, Csoszi T, Fulop A, Rodriguez-Cid J, Wilson J, Sugawara S, Kato T, Lee KH, Cheng Y, Novello S, Halmos B, Li X, Lubiniecki GM, Piperdi B, Kowalski DM; KEYNOTE-407 Investigators. Pembrolizumab plus Chemotherapy for Squamous Non-Small-Cell Lung Cancer. N Engl J Med. 2018 Nov 22;379(21):2040-2051. doi: 10.1056/NEJMoa1810865. Epub 2018 Sep 25.

Reference Type: BACKGROUND

PMID: 30280635 (View on PubMed)

Gabay C, Russo A, Raez LE, Rolfo Cervetto C. Adjuvant therapy in non-small cell lung cancer: is targeted therapy joining the standard of care? Expert Rev Anticancer Ther. 2021 Nov;21(11):1229-1235. doi: 10.1080/14737140.2021.1982387. Epub 2021 Sep 25.

Reference Type: BACKGROUND

PMID: 34528869 (View on PubMed)

Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, de Haes JC, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993 Mar 3;85(5):365-76. doi: 10.1093/jnci/85.5.365.

Reference Type: BACKGROUND

PMID: 8433390 (View on PubMed)

Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83.

Reference Type: BACKGROUND

PMID: 1593914 (View on PubMed)

Pompili C. Quality of life after lung resection for lung cancer. J Thorac Dis. 2015 Apr;7(Suppl 2):S138-44. doi: 10.3978/j.issn.2072-1439.2015.04.40.

Reference Type: BACKGROUND

PMID: 25984359 (View on PubMed)

Koller M, Warncke S, Hjermstad MJ, Arraras J, Pompili C, Harle A, Johnson CD, Chie WC, Schulz C, Zeman F, van Meerbeeck JP, Kulis D, Bottomley A; European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Group; EORTC Lung Cancer Group. Use of the lung cancer-specific Quality of Life Questionnaire EORTC QLQ-LC13 in clinical trials: A systematic review of the literature 20 years after its development. Cancer. 2015 Dec 15;121(24):4300-23. doi: 10.1002/cncr.29682. Epub 2015 Oct 9.

Reference Type: BACKGROUND

PMID: 26451520 (View on PubMed)

Koller M, Hjermstad MJ, Tomaszewski KA, Tomaszewska IM, Hornslien K, Harle A, Arraras JI, Morag O, Pompili C, Ioannidis G, Georgiou M, Navarra C, Chie WC, Johnson CD, Himpel A, Schulz C, Bohrer T, Janssens A, Kulis D, Bottomley A. An international study to revise the EORTC questionnaire for assessing quality of life in lung cancer patients. Ann Oncol. 2017 Nov 1;28(11):2874-2881. doi: 10.1093/annonc/mdx453.

Reference Type: BACKGROUND

PMID: 28945875 (View on PubMed)

Pompili C, Koller M, Velikova G. Choosing the right survey: the lung cancer surgery. J Thorac Dis. 2020 Nov;12(11):6892-6901. doi: 10.21037/jtd.2019.12.131.

Reference Type: BACKGROUND

PMID: 33282392 (View on PubMed)

Related Links

https://www.lungcancereurope.eu/wp-content/uploads/2022/06/6th-LuCE-Report_Web-version_Definitive.pdf

6th LuCE Report on lung cancer. Experiences and quality of life of people impacted by lung cancer in Europe

Other Identifiers

PI 2023 05 1296 - TD

Identifier Type: -

Identifier Source: org_study_id